ClinicalTrials.gg
RecruitingNCT06072066Updated Aug 27, 2024

Effects of Oral Supplement Containing L-Histidine and Antioxidants on the Skin Barrier Function and Systemic Inflammation in Rosacea

An interventional study of Skin Barrier Oral Supplement in Rosacea and Systemic Inflammation, sponsored by Integrative Skin Science and Research. Recruiting at 1 site in United States. Open to participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-27.

Sponsored by Integrative Skin Science and Research · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Nov 2023; still recruiting 2 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
30 Years to 70 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate how supplementation will alter the skin and the gut barrier and inflammation in those with rosacea.

Read the detailed description

Rosacea is a chronic inflammatory condition that widely prevalent in the general population and is associated with both inflammation and dysfunction of the skin barrier. Gut dysfunction has been shown to be present in those with rosacea. This study evaluates how the use of a supplement may improve the gut and skin barrier as well as reduce general inflammation.

02

Conditions studied

  • Rosacea
  • Systemic Inflammation

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Keywords

  • Rosacea
  • L-Histidine
  • Antioxidants
03

In context

Rosacea

233 studies on the registry are indexed under Rosacea; 23 are open to participants now.

This study's planned enrollment of 24 is below the median of 61 across 200 interventional studies indexed under Rosacea.

Browse Rosacea studies →

Lead sponsor

Integrative Skin Science and Research is the lead sponsor of 35 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Males and females 30 to 70 years of age
  • The presence of mild to moderate rosacea (erythematotelangiectatic or papulopustular)
  • High sensitivity C-reactive protein (hs-CRP) that is greater than or equal to 1.0 mg/L

Exclusion criteria

Exclusion Criteria:

  • The presence of severe rosacea as noted by the investigator global assessment.
  • Those who are unwilling to discontinue oral supplementation, or supplement ingredients found in the study's oral product 1 month prior to enrollment.
  • Discontinuation of oral L-glutamine or L-glutamine containing supplement 1 month prior to enrollment
  • Those who are unwilling to discontinue topical benzoyl peroxide or retinoids for 2 weeks prior to enrollment.
  • Those who are unwilling to keep their facial regimen the same throughout the study.
  • Individuals who have been on an oral antibiotic within the previous one month.
  • Individuals who are pregnant or breastfeeding.
  • Individuals who have changed any of their hormonal based or therapies within 3 months prior to joining the study.
  • Individuals on oral contraceptive pills or progesterone or estrogen containing therapies.
  • Use of isotretinoin within the three months prior to enrollment.
  • Individuals on finasteride or dutasteride
  • Current tobacco smoker, smoker within the past year, or greater than 5 pack-year tobacco smoking history.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Skin Barrier Oral Supplement

    Dietary Supplement: Skin Barrier Oral Supplement

Interventions

  • Dietary supplementSkin Barrier Oral Supplement

    Supplment powder

06

What researchers measure

Primary outcomes

  1. Transepidermal water loss (TEWL)

    Change in the facial transepidermal water loss (TEWL) using the Vapometer.

    Time frame: 8 weeks

  2. Blood hs-CRP level

    Change in blood hs-CRP level through blood spot testing

    Time frame: 8 weeks

Secondary outcomes

  1. Intestinal permeability

    Change in intestinal permeability through a urine based test by Genova Diagnostics

    Time frame: 4 weeks

  2. Intestinal permeability

    Change in intestinal permeability through a urine based test by Genova Diagnostics

    Time frame: 8 weeks

  3. Fecal levels of calprotectin

    Change in fecal levels of calprotectin through a stool sample

    Time frame: 4 weeks

  4. Fecal levels of calprotectin

    Change in fecal levels of calprotectin through a stool sample

    Time frame: 8 weeks

  5. Transepidermal water loss (TEWL)

    Change in the facial transepidermal water loss (TEWL) using the Vapometer.

    Time frame: 4 weeks

  6. Blood hs-CRP level

    Change in blood hs-CRP level through blood spot testing

    Time frame: 4 weeks

  7. Mood Questionnaire

    A survey to assess changes in mood

    Time frame: 4 weeks

  8. Mood Questionnaire

    A survey to assess changes in mood

    Time frame: 8 Weeks

  9. Digestive Questionnaire

    A survey to assess digestive health

    Time frame: 4 weeks

  10. Digestive Questionnaire

    A survey to assess digestive health

    Time frame: 8 weeks

Other outcomes

  1. Inflammatory lesions on the face

    Change in number of inflammatory lesions on the face

    Time frame: 4 weeks

  2. Inflammatory lesions on the face

    Change in number of inflammatory lesions on the face

    Time frame: 8 weeks

  3. Facial erythema

    Change in appearance of facial erythema measured by photographic analysis (BTBP 3D Camera System)

    Time frame: 4 weeks

  4. Facial erythema

    Change in appearance of facial erythema measured by photographic analysis (BTBP 3D Camera System)

    Time frame: 8 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06072066
Responsible party
Sponsor
First posted
Oct 10, 2023
Start date
Nov 22, 2023
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Aug 27, 2024

Study contacts

Caitlin Egli
Contact
research@integrativeskinresearch.com
916-750-2463

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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